News Report · Rheumatology

FDA Approves Immgolis for Rheumatoid Arthritis and Ulcerative Colitis: First Interchangeable Biosimilar to Simponi

June 14, 2026

Clinical Perspective

Rheumatologists and gastroenterologists can now consider Immgolis for patients with moderately to severely active rheumatoid arthritis and ulcerative colitis who meet treatment criteria. The approval of this interchangeable biosimilar provides a cost-effective alternative to Simponi, potentially improving access to therapy for many patients. How will the introduction of interchangeable biosimilars impact treatment decisions and patient outcomes in the long term?

Dr. Deepak Nair · Rheumatology

The FDA approved Immgolis (golimumab-sldi) for the treatment of moderately to severely active rheumatoid arthritis and ulcerative colitis on May 15, 2026, based on its status as an interchangeable biosimilar to Simponi (golimumab) ^[1].

Clinical Context

Rheumatoid arthritis (RA) is an autoimmune condition characterized by chronic inflammation of the joints, leading to pain and disability. Ulcerative colitis (UC) is a form of inflammatory bowel disease that causes inflammation and ulcers in the colon. Current treatments for RA and UC often include tumor necrosis factor (TNF) inhibitors, which have been shown to reduce inflammation and improve symptoms. However, access to these biologics can be limited by high costs and insurance coverage issues. The approval of Immgolis as an interchangeable biosimilar aims to improve patient access to effective treatment options for both RA and UC, potentially lowering costs and increasing the availability of these therapies.

Key Findings

The FDA approved Immgolis as an interchangeable biosimilar biological product to Simponi for the treatment of moderately to severely active rheumatoid arthritis (RA) and ulcerative colitis (UC) ^[1].
The trial data demonstrated that Immgolis is highly similar to Simponi, with no clinically meaningful differences in safety or effectiveness ^[1].
Immgolis is administered via subcutaneous injection in a single-dose prefilled syringe, while Immgolis Intri (another formulation) is administered as an intravenous infusion ^[1].
Both Immgolis and Immgolis Intri are indicated for adults with RA in combination with methotrexate and for UC ^[1].
The approval of Immgolis and Immgolis Intri marks the first time interchangeable biosimilars have been approved for these indications, providing a new treatment option for patients ^[1].
Dosing information for Immgolis is available in the prescribing information, ensuring that clinicians have access to the necessary guidance for administration ^[1].

Safety & Tolerability

Injection site reactions reported with Immgolis — exact frequency not available in public source summary ^[1].
Nausea reported — exact frequency not available in public source summary ^[1].
Fatigue reported ^[1].
Risk of serious infections — advise patients to seek medical attention for signs of infection ^[1].
Embryo-fetal toxicity — advise patients of reproductive potential to use effective contraception ^[1].
Complete adverse event profile available in the full prescribing information for Immgolis (golimumab-sldi) ^[1].

Study Design

The approval of Immgolis was based on comprehensive data demonstrating its biosimilarity to Simponi. The studies included analytical and clinical data showing that Immgolis has no clinically meaningful differences in safety, purity, and potency compared to the reference product. The follow-up duration and specific details regarding the study design were not disclosed in the available sources. Future studies may be needed to further assess long-term outcomes associated with the use of Immgolis in clinical practice.

FAQ

What is Immgolis approved for?

Immgolis (golimumab-sldi) is approved for the treatment of moderately to severely active rheumatoid arthritis and ulcerative colitis in adults as of May 15, 2026.

How does Immgolis work?

Immgolis is a TNF inhibitor that works by binding to tumor necrosis factor alpha (TNFα), preventing it from triggering inflammation, which helps improve the signs and symptoms of rheumatoid arthritis and ulcerative colitis.

What is the recommended dose of Immgolis?

Full dosing guidance is available in the prescribing information for Immgolis (golimumab-sldi).

What are the most common side effects of Immgolis?

Common side effects include injection site reactions, nausea, and fatigue. Patients should be monitored for signs of serious infections and advised on reproductive health considerations.

FDA Approves Immgolis for Rheumatoid Arthritis and Ulcerative Colitis: First Interchangeable Biosimilar to Simponi

FDA Approves Immgolis for Rheumatoid Arthritis and Ulcerative Colitis: First Interchangeable Biosimilar to Simponi

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

Get weekly drug updates for Rheumatology in your inbox.

Related Drug Updates

FDA Review of Anifrolumab (Saphnelo) Subcutaneous Formulation for Systemic Lupus Erythematosus

FDA Approves First Interchangeable Biosimilars for Rheumatoid Arthritis: Cost Savings and Formulary Implications

Biosimilars for TNF Inhibitors: Cost-Effective Options for Rheumatology in 2026

Verified HCP Portal